UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058191 |
|---|---|
| Receipt number | R000066463 |
| Scientific Title | The impact of self-selected music intervention on exercise therapy for Chronic Ankle Instability (CAI) |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/16 15:58:15 |
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Basic information
Public title
The impact of self-selected music intervention on exercise therapy for Chronic Ankle Instability (CAI)
Acronym
The impact of self-selected music intervention on exercise therapy for Chronic Ankle Instability (CAI)
Scientific Title
The impact of self-selected music intervention on exercise therapy for Chronic Ankle Instability (CAI)
Scientific Title:Acronym
The impact of self-selected music intervention on exercise therapy for Chronic Ankle Instability (CAI)
Region
| Japan |
Condition
Condition
Chronic Ankle Instability (CAI)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of music intervention on exercise therapy in patients with chronic ankle instability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight-Bearing Dorsiflexion Range of Motion
Ankle joint muscle strength
Y-Balance test
Side hop test
Key secondary outcomes
Foot and Ankle Ability Measure(FAAM)
Cumberland Ankle Instability Tool(CAIT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform exercise therapy while listening to music.
1. Peroneal muscle strengthening (peroneus longus and brevis)
Isometric contraction held for 5 seconds per repetition, repeated 20 times.
2. Balance Training
1) Single-leg stance with eyes open
60 seconds
2) Single-leg stance with eyes closed
60 seconds
3) Single-leg stance with ball toss on a flat surface
10 repetitions per set, repeated 2 times
4) Single-leg stance with ball toss on a balance pad
10 repetitions per set, repeated 2 times
3. Static stretching of the triceps surae
Held for 60 seconds per set, performed 4 times.
Interventions/Control_2
Perform exercise therapy without listening to music.
1. Peroneal muscle strengthening (peroneus longus and brevis)
Isometric contraction held for 5 seconds per repetition, repeated 20 times.
2. Balance Training
1) Single-leg stance with eyes open
60 seconds
2) Single-leg stance with eyes closed
60 seconds
3) Single-leg stance with ball toss on a flat surface
10 repetitions per set, repeated 2 times
4) Single-leg stance with ball toss on a balance pad
10 repetitions per set, repeated 2 times
3. Static stretching of the triceps surae
Held for 60 seconds per set, performed 4 times.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Based on the criteria of the International Ankle Consortium (IAC):
1. A history of at least one significant ankle sprain:
(1) The initial ankle sprain must have occurred more than 12 months prior to study enrollment.
(2) The initial sprain must have resulted in inflammatory symptoms, such as pain and swelling.
(3) The initial sprain must have caused at least one day of interrupted physical activity.
(4) The most recent sprain must have occurred at least 3 months prior to study enrollment.
2. A history of perceived ankle joint instability, giving way, or recurrent sprains:
(1) At least two episodes of giving way in the 6 months prior to study enrollment.
(2) A history of at least two sprains in the same ankle.
(3) A Cumberland Ankle Instability Tool (CAIT) score of 24 or less.
3. Functional limitation as assessed by self-reported questionnaires:
(1) Foot and Ankle Ability Measure (FAAM): Activities of Daily Living (ADL) subscale score of less than 90%.
(2) FAAM: Sports subscale score of less than 80%.
Key exclusion criteria
1. Have a history of musculoskeletal surgery (bone, joint, nerve, etc.) on either lower limb.
2. Have a history of fractures requiring alignment correction on either lower limb.
3. Within the past three months, have had an acute musculoskeletal injury (such as sprain or fracture) in other lower limb joints that affected joint integrity or function, resulting in at least one day of interrupted physical activity.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | HUIJING |
| Middle name | |
| Last name | NI |
Organization
Graduate School, Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
39-22, 3 chome, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7111
h251c011@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | HUIJING |
| Middle name | |
| Last name | NI |
Organization
Graduate School, Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
39-22, 3 chome, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7111
Homepage URL
h251c011@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Gunma University
Address
39-15, 3 chome, Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066463
